Obstruction of the urinary tract due to compression of the urethra by an enlarging prostate gland results in a number of symptoms in the patient, including nocturia, frequency of urination, stranguria and post-void dribbling, as well as the emotional problems of pain, discomfort and embarrasment. Generally, patients suffering from such symptomatic prostatism may pursue only two options; either, continue living with the pain and discomfort, or undertake major surgery known as prostatectomy Choosing the surgical procedure subjects the patient to a number of hazards, including post-operative bleeding, stricture formation at the urethra or bladder neck, incontinence, post-manipulation pain or bladder spasm, urinary infection, reactive urethral swelling causing urinary obstruction and epididymitis. Further risks include wound infection, retention of prostatic chips, retrograde ejaculation, bladder perforation, hyponatremia, intravascular hemolysis, and impotency. Moreover, simple prostatectomy requires at least 1 to 3 hours in the operating room, followed by an average of one week in the hospital and in complicated cases, two or more weeks. About 10 to 15% of prostatectomy patients ultimately require a repeat prostatectomy and probably 10% develop strictures with long term cost considerations. Conversely, choosing to abstain from surgery neither alleviates the patient's pain or discomfort nor reduces the probability that more serious future prostate problems will occur.
A number of methods have been used to try and treat prostatism other than with surgery. Such methods frequently utilize the injection of medications into the prostate gland by means of a catheter. These injections are frequently ineffective due both to the poor absorption of antibiotics by the prostate gland, as well as to the difficulty inherent in positioning and retaining the catheter with respect to the affected area, and generally result in reoccuring prostatic disorders following a short period of time. Alternatively, U.S. Pat. Nos. 3,977,408; 2,642,874; and 550,238 teach that distally fixed balloons have been implemented to hold catheters in place while medication is applied to the prostate gland. Balloons located along two sections of a catheter have been used to isolate an area within the urethra, as taught in Gants, U.S. Pat. No. 2,936,760 and Allen, U.S. Pat. No. 550,238.
While balloon catheters have also been used to expand the bladder in order to measure the pressure within the bladder, as expounded in U.S. Pat. Nos. 3,977,391; 4,407,301; 4,191,196 and 4,072,144. Utilizing catheters to seal off an area of the urethra prior to injecting a liquid has been suggested by Rowe, U.S. Pat. No. 2,078,686 and Keeling, U.S. Pat. No. 3,977,408. And, finally, a balloon catheter has also been used to apply pressure following surgery in order to stop bleeding. Examples of such a use are taught in Layton, U.S. Pat. No. 4,219,026 and in Schulze, U.S. Pat. No. 4,141,364. Notwithstanding this concentration of balloon associated catheters, it is certainly clear that none of the prior articles suggest nor anticipate utilizing the balloon itself to dilate the prostatic urethra, as in the present invention. Rather, the prior art teaches only a mechanical stabilizing use subservient to the present invention's intended function of treating an enlarged prostate gland; for which none of these methods have been effective.